At Abbott, we're committed to helping you live your best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 94,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
Senior Counsel, Regulatory is an intermediate individual contributor position for lawyers in Abbott’s Legal Division. Responsible for counseling on FDA laws, regulations, and guidance documents with respect to complex regulatory issues relating to the development, approval, and marketing of medical devices; product cybersecurity; lifecycle management; as well as inspectional and product safety/quality issues.
Core Job Responsibilities
Senior Counsel, Regulatory:
Collaborates with cross-functional teams and counsels a variety of clients across Abbott’s medical device businesses on moderately complex legal regulatory issues, such as: product design and validation, product submissions, product field actions, patient complaints, agency inspections, advertising and promotion, and manufacturing requirements;
Resolves routine and moderately complex to complex legal regulatory matters with minimal supervision;
Keeps abreast of changes in laws and regulations that affect the regulation of Abbott’s medical devices, and identifies opportunities to influence content and engages in external influencing efforts;
Interacts and provides legal and strategic guidance to senior management and functional organizational leadership;
Helps select and directs the work of outside counsel, defines project objectives and manages project to ensure the work, strategy and costs meet Abbott’s expectations; and
Conducts regulatory due diligence in connection with any potential medical device acquisition activities.
Located at Abbott’s headquarters in Abbott Park, Illinois (preferred); however, one of Abbott’s medical device businesses in California may be a possible alternative.
Advises legal department managers of critical project developments in a timely manner.
Executes core job responsibilities in a timely manner.
Assigned matters may have a moderate impact on business activities and operations.
Advises Managers, Directors, General Managers and Division Vice Presidents.
No direct department budget responsibility; must however operate within budget. Develops budgets for assigned legal matters with supervision from more experienced attorneys.
Juris Doctor degree
Generally 7+ years of experience and demonstrated expertise in providing legal counsel on medical device regulatory and quality matters with a major corporation or law firm; prior cybersecurity expertise or government experience is also beneficial
Must have demonstrated ability to manage attorneys and/or paralegals, and to perform successfully in cross-functional teams, with the ability to lead and mentor
Must have ability to handle multiple projects in fast-paced environment and exercise sound commercial and legal judgment
In addition to top-notch legal skills, must have excellent interpersonal, strategic thinking, communication and organizational skills
Yes, 25% of the time
Internal Number: 30873233
Abbott is about the power of health. For more than 125 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 150 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.
The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges.
An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.